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10-Q
BIOTIME INC filed this Form 10-Q on 08/09/2017
Entire Document
 

By virtue of consent that I received from the CEO of the Israeli Ministry of Health, I have the right to approve the experiments with human beings in Hadassah Medical Institution. After the application to make such experiment was approved by the Helsinki Committee on August 27, 2009, and after I was convinced that the experiment was in accordance with the principles of the Helsinki Declaration and the Israeli Public Health Regulations-1980, and that the agreement  between the Initiator of the experiment, the Leading researcher and the Medical Institution complies with the principals of experiments on human beings, I hereby approve the extension of the experiment.
 
The terms of the approval:
 
1.
The clinical trial will be done in accordance with the Helsinki Declaration and in accordance with the principals of Experimenting with Human Beings in Israel (2006) and in accordance with the international updated regulations in such experiments.
2.
This approval of the experiment for the clinical trial is subject to the Helsinki Committee conditions.
1.
The Helsinki Committee Conditions are as following:
2.
The expiration date of the experiment is October 31, 2010.
3.
The patient will receive a treatment, only after an explanation has been given to the patient or his representative. The patient must sign an informed consent form.
4.
Any change, amendment or deviation from the protocol of the clinical trial/experiment, requires the written approval of the Ethics Committee or the Ministry of Health.
5.
The leading researcher shall report to the Helsinki Committee and to the “Main Initiator of the Experiment” regarding any serious adverse event that occurred during the trial or the termination of the trial (as detailed in section 15.1.1 of the procedure, within 48 hours of the event being known to him). The Helsinki Committee will review the submitted report and will forward its opinion to the Ministry of Health.
6.
In order to extend the term of the experiment, an application must be submitted (2 months prior the expiration date of the experiment). In the application for the extension, the leading researcher must describe his progress in the experiment. If such application is not be submitted timely, the experiment will not be extended and will be terminated.
7.
At the end of the experiment, the leading researcher, shall submit a summary of the experiment and its results.
 
[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 
 
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